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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT
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CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405672
Device Problem Defective Device (2588)
Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994)
Event Date 03/20/2019
Event Type  Injury  
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001275539, medical device expiration date: 2020-09-30, device manufacture date: 2018-12-03.Medical device lot #: 0001269741, medical device expiration date: 2020-06-30, device manufacture date: 2018-10-30.Pma/510(k)#: enforcement discretion.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 2 trays spn whit25g3.5 l/b-d/e blue drape from lot # 0001275539, and 2 trays spn whit25g3.5 l/b-d/e blue drape from lot # 0001269741 were ineffective at relieving pain, with the patient retaining feeling in the leg and able to lift it after anesthesia was administered.Higher blood pressure in the patient was also reported during the event, and additional anesthesia and after-surgery pain medication had to be given as a result.This complaint was created to capture 1 of 2 related incidents.The following information was provided by the initial reporter: "4 trays not give patients pain relief.1 case they were still having feeling and could lift their leg up.1 case rated pain 4 out of 10 in recovery.Higher blood pressures during each of the cases.Which then in turns them receiving more anesthesia and pain meds after surgery.".
 
Event Description
It was reported that 2 trays spn whit25g3.5 l/b-d/e blue drape from lot # 0001275539, and 2 trays spn whit25g3.5 l/b-d/e blue drape from lot # 0001269741 were ineffective at relieving pain, with the patient retaining feeling in the leg and able to lift it after anesthesia was administered.Higher blood pressure in the patient was also reported during the event, and additional anesthesia and after-surgery pain medication had to be given as a result.This complaint was created to capture 1 of 2 related incidents.The following information was provided by the initial reporter: "4 trays not give patients pain relief.1 case they were still having feeling and could lift their leg up.1 case rated pain 4 out of 10 in recovery.Higher blood pressures during each of the cases.Which then in turns them receiving more anesthesia and pain meds after surgery.".
 
Manufacturer Narrative
Investigation: a dhr review of all applicable manufacturing records did not identify any issues that may have contributed to the reported failure mode.No sample was returned for analysis.Based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.The investigation identified a previous capa (capa 67717) performed by the bd anesthesia quality group that specifically investigated the ¿ineffective anesthesia¿ failure mode.Refer to capa 67717 for additional information regarding the outcome of the investigation.Likewise, the investigation identified a summary for previously investigated complaints (pic: (b)(4)) which provides rationale and information regarding the potential ineffective anesthesia outcome during the use of an anesthesia product code.Based on a review of all of these sources, the current complaint investigation could not identify a definitive root cause nor could any potential contributor be identified for this specific complaint failure mode.
 
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Brand Name
TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key8510224
MDR Text Key141941839
Report Number1625685-2019-00021
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904056728
UDI-Public00382904056728
Combination Product (y/n)N
PMA/PMN Number
SEE H.10.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405672
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? No
Date Manufacturer Received03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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